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FDA 510(k)

MODIFICATION TO:NESS L300

K-Number: K080219 · 2008-02-28

ApplicantNess-Neuromuscular Electrical Stimulation Systems
Decision Date2008-02-28
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:NESS L300 is the device name listed in this FDA 510(k) record. The listed applicant is Ness-Neuromuscular Electrical Stimulation Systems. It received FDA 510(k) clearance on 2008-02-28 under 510(k) number K080219. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO:NESS L300?

MODIFICATION TO:NESS L300 is a medical device that received FDA 510(k) clearance on 2008-02-28. The listed applicant is Ness-Neuromuscular Electrical Stimulation Systems. The 510(k) number is K080219.

When did MODIFICATION TO:NESS L300 receive FDA 510(k) clearance?

MODIFICATION TO:NESS L300 received FDA 510(k) clearance on 2008-02-28, under 510(k) number K080219.

Who is the listed applicant for MODIFICATION TO:NESS L300?

The FDA 510(k) record lists Ness-Neuromuscular Electrical Stimulation Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO:NESS L300?

The FDA product code for MODIFICATION TO:NESS L300 is GZI.

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Other records listing Ness-Neuromuscular Electrical Stimulation Systems as applicant

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K111767NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KITK053468NESS L300K031900HANDMASTERK024279NESS CHILDREN SYSTEMK022776NESS SYSTEMK012823MODIFICATION TO HANDMASTER

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Related Devices (Code: GZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242704Synchrony (20-3000)Synapse Biomedical, Inc.K243828CIONIC NEURAL SLEEVE (NS-200)Cionic, Inc.K240632Neuvotion NeuStim NN-01Neuvotion, Inc.K233006MyndMove, MyndMove 2.0Myndtec, Inc.K230997EvoWalk 1.0 SystemEvolution Devices, Inc.K221823Cionic Neural Sleeve NS-100Cionic

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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